Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

Last updated: October 28, 2008
Sponsor: Daiichi Sankyo, Inc.
Overall Status: Completed

Phase

3

Condition

Otitis Media

Ear Infections

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT00781521
8280A-PRT021
  • Ages 6-12
  • All Genders

Study Summary

This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • 6 months of age to <12 years of age

  • weight = or >4.5 kg

  • Patent tympanostomy tube(s) in the affected ear(s)

  • Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin

Exclusion

Exclusion Criteria:

  • Non-bacterial otic infection

  • Known or suspected hypersensitivity to ofloxacin

  • Cystic fibrosis

  • HIV infection

  • Neutropenia

  • Receiving immunosuppressive therapy

Study Design

Total Participants: 96
Study Start date:
November 01, 2002
Estimated Completion Date:
April 30, 2003